A Phase 1, Single-Center, Single-Blind, Placebo and Propofol Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous (IV) Infusion Doses of ABP-700
- Conditions
- Preliminary safety study
- Registration Number
- NL-OMON25748
- Lead Sponsor
- Annovation Biopharma, University Medical Center Groningen (UMCG)
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
1.Healthy, adult, men and women, 18-45 years of age, inclusive.
2.Continuous non-smoker who has not used nicotine-containing products for at least 6 months prior to the first dose.
Exclusion Criteria
1. History or presence of significant cardiovascular disease, or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome.).
2.History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological (inclusive of any seizure disorder), or psychiatric disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of a single ascending intravenous (IV) infusion doses of ABP-700.<br><br /><br /><br>To determine the maximum tolerated dose (MTD) of intravenous infusion doses of ABP-700.<br>
- Secondary Outcome Measures
Name Time Method To characterize the pharmacokinetics (PK) of ABP-700 and its primary metabolite (CPM-acid).<br><br /><br /><br>To assess the pharmacodynamics (PD) of ABP-700.<br><br /><br /><br>To investigate the dose-response and PK/PD relationships.<br>